510(k) · Cleared
ClearedKarl Storz Ureter Resectoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · FJL Resectoscope
Cleared on May 1, 1996 after a 68-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- May 1, 1996
- Review
- 68 days
- Class
- Class II
- Product code
- FJL
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK960757 Karl Storz Ureter ResectoscopeKARL STORZ Endoscopy-America, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK060232 Trokamed GMBH Electrosurgical Instruments & AccessoriesTrokamed GmbH · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK261179 AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbH · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960757 | Karl Storz Ureter Resectoscope | KARL STORZ Endoscopy-America, Inc. | 1996 | — |
| +1 | K060232 | Trokamed GMBH Electrosurgical Instruments & Accessories | Trokamed GmbH | 2006 | 10 |
| +2 | K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FJL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FJL device
- #1 K221893 KARL STORZ Bipolar Resectoscopes with HF Cablescore 7.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060232 | Trokamed GMBH Electrosurgical Instruments & Accessories | 2006 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060232 (Trokamed GmbH, 2006) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FJL devicesFJL Resectoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FJL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FJL
Too few FJL 510(k)s in any year since 2007 to give a median.
Recalls per year · FJL
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FJL
67in 2025
MAUDE reports naming product code FJL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 11 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 15 |
| 2010 | 1 | — | 0 | 34 |
| 2011 | 0 | — | 0 | 18 |
| 2012 | 0 | — | 0 | 26 |
| 2013 | 0 | — | 1 | 24 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 1 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 50 |
| 2019 | 2 | — | 0 | 53 |
| 2020 | 0 | — | 0 | 55 |
| 2021 | 0 | — | 0 | 54 |
| 2022 | 0 | — | 1 | 74 |
| 2023 | 2 | — | 0 | 74 |
| 2024 | 1 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 67 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KSEA ureter resectoscope is designed to be used for diagnostic and therapeutic procedures in the transurethral resection of tissue in the ureters and renal pelvis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960757: Karl Storz Ureter Resectoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960757
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026